Calibration and Qualification in Analytical Laboratories

Product Id : 600438

Globalcompliancepanel

Training Options

  •   Duration: 75 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use.

Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document.

For easy implementation, attendees will receive:
  • 4 SOPs
    • User Requirement Specifications (URS) for analytical equipment
    • Change control for analytical equipment
    • Qualification of equipment
    • Allocating Analytical Instruments to USP <1058> Categories
  • Allocating Analytical Instruments to USP <1058> Categories
Areas Covered in the Session:
  • Operational lab equipment requirements for calibration and qualification
  • Most common inspection problems
  • USP Chapter <1058>: Analytical Instrument Qualification
  • Development of an effective equipment qualification master plan
  • Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • Allocating equipment to qualification categories A, B and C
  • Qualification and documentation requirements for each category
  • Going through the category example list
  • Approach for existing systems
  • Approach for automated systems (incl. firmware/computer systems)
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • Documentation requirements
Who Will Benefit:
  • QA managers and personnel
  • Analysts and lab managers
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultans
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.


Related Webinars:

No Related Webinars Available


About Us

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
  Phone: +1-800-447-9407
  Fax: 302 288 6884
     Copyright © 2014 GlobalCompliancePanel. All rights reserved. Netzealous
USAePay
Back to Top